(Sr.) QA Safety Specialist

中国, 上海, Shanghai

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Job Summary职位概述:
1.    Organize to define quality system, guide and supervise the implementation, to ensure company complies with applicable RD Quality Standards and local regulatory requirements.
组织制订公司质量管理制度,方针并监督其执行,确保公司符合总部的质量标准和当地质量法规要求。
2.    Act as Local safety officer, lead PMS team to ensure post-market surveillance implementation to fulfill global standard and local regulation.
作为代理地方安全官,带领PMS团队确保公司上市后监管的执行符合总部相关质量标准定及当地法规要求。

Main  Tasks & Responsibilities主要工作职责 :
1.    Handle product quality complaint management, case monitoring and AE management to fulfill global standard and local regulation. 
负责品质量投诉、产品/事件监控流程和不良事件报告的管理,确保符合当地法规和总部相关要求。
2.    Responsible for global product notification (QN& SBN) communication, execute and contact local authority to fulfill global standard and local regulation.
负责总部产品通知(质量通知和召回)的沟通和执行并报告当地药监,确保符合当地法规和总部相关要求。
3.    Responsible for product quality compensation process management
负责与质量问题有关的产品补偿流程的实施。
4.    Quality Documents & Records Control and Change Control. Keep records. Have clear filing and maintain of all documents. 
质量文件、记录的控制及变更文件的控制。文件分类归档,保留完好。
5.    Coordinate and support for External Audit, Internal Audit.
协助及支持完成公司内部及外部的质量方面的稽查工作。
6.    Other projects or tasks assigned by line manager.
主管指派的其他任务。
7.    Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
遵循罗氏所有合规要求,包括但不限于罗氏信息安全,罗氏商业中的行为,罗氏竞争法互动对话,罗氏安全健康环境等,合法合理开展业务活动。

Education& Qualifications教育背景与专业资格:
1.    Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry; license pharmacist or laboratory technician-in-charge preferred
医学/ 生物工程/ 临床或生化专业本科以上学历。具有执业药师或主管检验师职称优先。
2.    Proficiency in both spoken and written English 
熟练掌握英语口语及书面表达
3.    Have ISO13485 internal auditor qualification or above
ISO13485质量管理体系内审员以上资格

Experience工作经验:
1.    Have above 3-year QA experience, especially above 1-year experience in post-market surveillance.   
3年以上质量保证工作经验,其中1年以上上市后监管工作经验
2.    Experience of working in Foreign Invested Company /Multi-national Company is preferred.
外企(跨国公司)工作经验优先。